This invention relates to a cassette for surgical irrigation and aspiration and a sterile package for such cassette. More particularly, this invention relates to a cassette for use with an ocular ultrasonic surgical device. Still more particularly, this invention relates to a cassette for an ultrasonic surgical device wherein the cassette is supplied with both irrigation and aspiration tubes and a waste bag assembled and packaged in a sterile package.
In connection with surgical procedures of various types or, more generally, in connection with medical treatments, a number of various types of apparatuses are known for controlling the flow of fluid from a source to a patient. In such devices, various mechanisms have been developed for controlling the flow of fluid from a source to a patient. In such devices, various mechanisms have been developed for controlling the flow of fluid through a fluid infusion or extraction system at a designated rate. In such systems, it has become desirable, for a number of reasons, to utilize a single use cassette in connection with such devices. In particular, devices are known for use in conjunction with a prepackaged disposable fluid processing module of a type which includes a housing wherein fluid containers, tubing segments, and other components required in the processing of fluid are contained to cooperate with various means for establishing a fluid circuit and controlling the flow of fluid through such a circuit.
On the other hand, an ocular ultrasonic surgical device is known to the art and described generally in U.S. Pat. No. 3,589,363. In that device, a hand-held ultrasonic vibrating tool is used to break apart and remove unwanted material in a surgical procedure especially adapted for surgical operations, such as cataract removal. In such a device, electrical connections are provided for supplying ultrasonic power to the handpiece and fluid connections are provided for controlling the supply of treatment fluid and the aspirative withdrawal of the suspension of tissue particles in the fluid from the operative site. Such devices include regulation techniques to control pressure within limits at the operative site. Thus, emulsifier/aspirator devices have been available to the art for use in connection with cataract surgery.
It is to an improvement in such devices that this invention is primarily directed, by providing a cassette which houses a portion of both the aspiration and irrigation manifolds for a simple yet reliable connection to the emulsifier/aspirator device.
The surgical team that performs a cataract procedure typically consists of a primary surgeon, an optional assistant surgeon, a scrub nurse, an anethesiologist, and a circulator or non-sterile nurse. The primary and assistant surgeons and the scrub nurse directly perform the cataract procedure and are in the sterile field. Since a cataract procedure requires transfers between the sterile and non-sterile fields, the circulator acts as the liaison for the surgical team between the sterile and the non-sterile fields. A responsibility of the circulator is to deliver sterile items, such as disposables or emergency surgical devices, to the sterile field and accept transfer of components necessary to set up the equipment being used.
In connection with prior art ophthalmic procedures, the circulator generally opened a package or packages sometimes in the form of pouches or trays, that contained the irrigation and aspiration manifolds for use in the ophthalmic procedure, and aseptically transferred them to the sterile field. The scrub nurse then located those ends of each manifold that required connection to the instrument and, while holding each manifold at a different time, transferred each manifold back to the circulator who respectively connected the irrigation manifold to an irrigation solenoid located on the equipment. A vent chamber on the irrigation manifold was then inserted into an appropriate irrigation source and the manifold was suspended on an IV pole. Thereafter, the circulator connected the aspiration manifold to the vacuum control system and to a rotary peristaltic pump located on the equipment. The circulator then took the manifold exiting the peristaltic pump and placed its end into a drainage bag which the circulator had previously attached to the equipment. At this point, the manifolds were ready for priming and system checkout.
Thus, in connection with the apparatus of the prior art, the set up procedure prior to this invention consisted of five connections made by the circulator to the equipment. Two of the connections were for the irrigation manifold and three were for the aspiration manifold. The attachment of the irrigation manifold to the irrigation solenoid consisted of inserting the irrigation tubing in the irrigation solenoid. In addition, attachment of the silicone pump tubing on the aspiration manifold to the aspiration pump roller assembly on the equipment also required dexterity and knowledge of equipment functions. If either the vacuum control connection or the pump connection were improperly made, the aspiration manifold might be unable to achieve a proper vacuum during the surgical procedures.
The number of transfers required prior to this invention were variable, requiring three or four transfers, and depended upon the exact method of packaging. If the manifolds were packaged in separate single pouches, then the circulator opened each outer pouch and transferred each inner pouch into the sterile field. Either of these two methods required two separate transfers into the sterile field. If the manifolds were packaged so that they were doubly-wrapped in trays, only one transfer was required into the sterile field. However, in any case, once the manifolds are in the sterile field, the scrub nurse must locate those ends of each manifold that must be transferred one at a time back to the circulator for equipment setup. In addition, extreme care must be taken when individually transferring the manifolds to avoid a risk of contamination of the scrub nurse or sterile field.
Thus, it is an overall object of this invention to provide a cassette for use in connection with a surgical procedure which makes convenient an interchange between the sterile and non-sterile fields in an ophthalmic procedure.
It is another object of this invention to provide a cassette which minimizes the steps between the sterile and non-sterile fields to prepare the aspiration and irrigation manifolds ready for priming and system checkout.
It is another object of this invention to provide a cassette for use with an ophthalmic device to minimize the connections made to the equipment.
It is still another object of this invention to provide a cassette which houses a portion of each of the irrigation and aspiration tubing together with a drain bag structured so that all fluidic connections are precisely made to the equipment by insertion of the cassette into the equipment, so that the reliability of the fluidic connections is transferred from a person to the construction and geometry of the cassette and mating cassette mechanism.
It is still another object of this invention to provide packaging for the cassette which limits the minimum number of transfers to two, i.e. a transfer of a transfer tray into the sterile field and a transfer of a transfer tray and the remaining portion of the cassette back to the non-sterile field so that the remaining portion of the cassette stays in the transfer tray during this transfer, thus reducing the risk of contamination.
These and other objects of the invention will become apparent from the following written description of the invention taken together with the accompanying drawings.